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PubMed1989

Enhancement in rats by the liver tumor promoter ethinyl estradiol of a serum factor(s) which is stimulatory for hepatocyte DNA synthesis.

Fractionation of female rat serum or plasma on Sephadex G-200 revealed the presence of an activity stimulatory for hepatocyte DNA synthesis. Treatment of female rats with the liver tumor promoter ethinyl estradiol (EE) at 2.5 micrograms/day caused a 1.6 fold increase in the level of this activity at 24 hr in both serum and plasma. The stimulatory activity had a molecular weight of 135 kD, was sensitive to trypsin and heating and was not inhibited by the antiestrogen tamoxifen or antibody to epidermal growth factor (EGF). However, the pooled active fractions from EE-treated rats competed to a greater extent than comparable fractions from control rats for specific [125I]-EGF binding to rat liver membranes. These results demonstrate that treatment of female rats with EE, under conditions known to stimulate liver growth, caused an increase in level of a factor(s) stimulatory for hepatocyte DNA synthesis and whose activity may be mediated through the EGF receptor.

Animals↗
PubMed2005

Safety and efficacy of an extended-regimen oral contraceptive utilizing continuous low-dose ethinyl estradiol.

OBJECTIVE: To assess the efficacy and safety of Seasonique, a 91-day extended-regimen oral contraceptive (OC) utilizing continuous low-dose ethinyl estradiol (EE) during the typical hormone-free interval. METHODS: A multicenter, open-label, 1-year study of Seasonique [30 microg EE/150 microg levonorgestrel (LNG)] for 84 days followed by EE 10 microg for 7 days was conducted in sexually active, adult women of childbearing potential. All patients completed daily electronic diaries to monitor compliance and bleeding. RESULTS: Method failure rate was 0.78 (Pearl index) and 0.64% (life table analysis). Cycle control and safety of the regimen were similar to that reported for other OCs. CONCLUSION: This study demonstrates that Seasonique is effective, safe and well tolerated for the prevention of pregnancy.

Adolescent↗
PubMed1992

Serum growth hormone (GH)-binding protein and insulin-like growth factor-I levels in Turner's syndrome before and during treatment with recombinant human GH and ethinyl estradiol.

Serum levels of GH-binding protein (GH-BP) and insulin-like growth factor-I (IGF-I) were measured in 14 adolescent girls with Turner's syndrome (TS) before and during treatment with recombinant human GH (rhGH) and oral ethinyl estradiol (EE2). Before treatment, the mean +/- SE GH-BP level in TS patients was 33.2 +/- 2.0%; this was higher (P < 0.05) than that in bone age-matched (27.9 +/- 1.1%; n = 13) or chronological age-matched (28.1 +/- 0.8%; n = 17) control girls. The mean +/- SE IGF-I level in TS girls (283 +/- 26 micrograms/L) was comparable to that in bone age-matched controls (255 +/- 17 micrograms/L), but lower (P < 0.005) than that in chronological age-matched pubertal controls (568 +/- 35 micrograms/L). In 7 TS girls treated with daily sc injections of rhGH in a dose of 0.8 U/kg.week for 18 months, serum levels of IGF-I increased from 330 +/- 39 to 707 +/- 48 micrograms/L after 3 months of treatment and remained elevated for the entire observation period (P < 0.002). In contrast, GH-BP levels did not change significantly. In 7 other TS girls, puberty was induced after 2 yr of daily sc injections with rhGH (1 U/kg.week) by adding 100 ng/kg.day EE2, orally, during ongoing rhGH therapy. During 18 months of pubertal induction, serum GH-BP levels increased gradually from 31.4 +/- 2.7% at the start of EE2 treatment to a maximum of 49.2 +/- 0.8% after 1 yr (P < 0.001). Serum IGF-I levels, in contrast, did not change significantly. These results show that in adolescent TS patients 1) pretreatment serum GH-BP levels are higher than in bone age-matched or chronological age-matched control girls, and IGF-I levels are similar to those in bone age-matched but lower than those in chronological age-matched controls; 2) during rhGH treatment GH-BP levels do not change, whereas IGF-I levels increase significantly; and 3) oral EE2 treatment during ongoing rhGH treatment increases GH-BP levels markedly, but does not modify IGF-I levels.

Adolescent↗
PubMed1990

Growth-promoting effect of growth hormone and low dose ethinyl estradiol in girls with Turner's syndrome.

Forty patients with Turner's syndrome, aged 5.0-16.6 yr, were randomly allocated to receive daily sc injections of recombinant human GH (hGH) at a dose of 1 IU/kg.week alone (group I) or in combination with 25 ng/kg.day ethinyl estradiol (E2; group II). The mean pretreatment height velocity was 3.8 cm/yr for both groups. During the first year of treatment height velocity increased significantly (P less than 0.001) in both groups, to 7.5 +/- 1.3 and 8.1 +/- 1.6 cm/yr, respectively. The difference between the two groups was not significant. The mean (+/- SD) height velocity expressed as the SD score for chronological age (Turner references) was 0.0 +/- 1.2 for group I and 0.2 +/- 1.4 for group II and increased significantly (P less than 0.001) during the first year of treatment to +4.3 +/- 1.1 in group I and +5.4 +/- 1.2 in group II. The difference between both groups was statistically significant (P less than 0.01). Height SD score for chronological age (Turner references) increased from -0.2 +/- 0.9 to +0.6 +/- 1.0 in group I and from -0.2 +/- 1.0 to +0.7 +/- 1.1 in group II. Mean bone age progressed similarly in both treatment groups (1.1 +/- 0.6 yr during 1 yr of treatment). However, bone age maturation accelerated more rapidly in younger patients. Twelve girls (three in group I and nine in group II) had minor breast development. No major adverse effects were reported. We conclude that daily sc therapy with hGH stimulates height velocity in Turner's syndrome. The beneficial effect on height velocity increment of E2 addition was small. Furthermore, even very low doses of E2 may induce breast development at an early age and accelerate bone maturation. For these reasons, the addition of E2 to hGH is not warranted in young patients with Turner's syndrome.

Adolescent↗
PubMed1983

Effects of short-term treatment with gonadotropin-releasing hormone (GnRH) or ethinyl estradiol on the pituitary responsiveness to GnRH.

In 4 patients with hypothalamic amenorrhea, the pituitary responsiveness to an intravenous challenge of 20 micrograms synthetic gonadotropin-releasing hormone (GnRH) was evaluated before and following a 3-days treatment course with GnRH (100 micrograms/per day i.m.) or ethinyl estradiol, (100 micrograms/day orally). The amenorrheic patients all had normal or reduced levels of serum gonadotropins, no evidence of galactorrhea and no other endocrine abnormality. Following GnRH treatment basal luteinizing hormone levels as well as the luteinizing hormone and follicle-stimulating hormone responses to GnRH were markedly reduced when compared with responses to GnRH before the treatment. Responses to GnRH were significantly augmented after treatment with estrogens. In patients with previous treatment with GnRH the augmented estrogen-induced LH response to GnRH was abolished. These preliminary results support the pathophysiological concept that in amenorrheic patients with hypothalamic dysfunction long-term administration of GnRH does not result in an improvement but rather in a deterioration of pituitary gonadotropic function.

Adult↗
PubMed1991

Sequentially administered ethinyl estradiol and medroxyprogesterone acetate in the treatment of refractory epithelial ovarian carcinoma in patients with positive estrogen receptors.

The activity of sequentially administered hormonal therapy was investigated over 25 days in 25 patients with epithelial ovarian carcinoma who had estrogen receptor (ERc)-positive tumors. Patients received ethinyl estradiol (EE) (50 micrograms/d) on days 1 to 7 and medroxyprogesterone acetate (MPA) (400 mg/d) on days 8 to 25. Twenty-three patients completed one or more courses of treatment. There were no complete responses (CR). Four partial responses (PR) with durations of 9, 4, 3, and 1 months were seen. Two incomplete responses with durations of 6 and 4 months were also seen. Six patients had stable disease (SD), and 11 patients had progression. The overall response rate was 17% and may represent a modest improvement in response over those in previously published studies conducted with MPA alone. No significant toxic effects were noticed, and some patients reported an improved sense of well-being. However, two patients experienced depression with this treatment. The mean ERc values in responders, patients with SD, and nonresponders were 70.0, 36.7, and 47.9 fmol/mg cytosolic protein, respectively. Future studies of hormonal therapy in patients with ovarian carcinoma should attempt to identify more reliable indices for determining sensitivity to these agents.

Administration, Oral↗
PubMed1987

Organ specific modifying potential of ethinyl estradiol on carcinogenesis initiated with different carcinogens.

Estrogen has been shown to exert a modifying potential on carcinogenesis in various organs, and in particular the hormone-dependent tissues. The present experiments were carried out to determine the effects of post-initiation phase administration of ethinyl estradiol (EE) on tumor development in the liver, kidney, lung, thyroid, bladder and esophagus of male F344 rats. Animals were initiated by 2 weeks treatment with 0.05% N-bis(2-hydroxypropyl)nitrosamine (DHPN), 0.1% N-ethyl-N-hydroxyethylnitrosamine (EHEN), 0.03% N-nitrosopiperidine (NPD), 0.02% 2-acetylaminofluorene (2-AAF) or 0.05% N-butyl-N-(4-hydroxybutyl)nitrosamine (BBN) in their diet or drinking water, and starting 1 week after initiation, they were given diet with or without a 0.001% EE supplement for 49 weeks, at which point the experiment was terminated. EE significantly increased the development of tumors of the liver (DHPN-, EHEN-, 2-AAF- and NPD-treated groups) and kidneys (EHEN-treated group) but inhibited their development in the lungs (DHPN-treated group) and urinary bladder (BBN-treated group). In the liver, EE also increased the development of glutathione S-transferase P type-positive lesions to various extents depending on the initiator used. EE administration was associated with a decreased incidence of esophageal hyperplasia in the EHEN-initiated group but an opposite increase in the NPD-initiated animals. No effect of EE was evident regarding thyroid lesions.

2-Acetylaminofluorene↗
PubMed2004

Short-term variations in bone remodeling markers of an oral contraception formulation containing 3 mg of drospirenone plus 30 microg of ethinyl estradiol: observational study in young postadolescent women.

The clinical study of treated subjects and nontreated controls was made in healthy eumenorrheic young postadolescent women volunteers in the Department of Obstetrics and Gynaecology at Cagliari University, to investigate whether an oral contraceptive (OC) containing drospirenone (3 mg) plus ethinyl estradiol (30 microg) (DRSP+EE) can affect bone metabolism. Control group (n = 26) and OC group (n = 28) women did not differ in age, body mass index, waist-to-hip ratio and main outcome measures [urinary levels of deoxypyridinoline and pyridinoline, serum levels of osteocalcin, bone specific alkaline phosphatase (bSAP), total testosterone (total-T), sex hormone-binding globulin (SHBG), progesterone and bone mineral density (BMD) at the heel]. The control group was studied at the luteal phase (LP) during both the first and the sixth menstrual cycle; the OC group was studied during the first cycle at the LP, and on days 16-18 of the sixth cycle of DRSP+EE treatment. At the sixth cycle, in the control group, the main outcome measures did not change compared to baseline. In the OC group, deoxypyridinoline, pyridinoline, osteocalcin, bSAP, total-T and progesterone levels were reduced, whereas SHBG levels were increased. The BMD was unchanged compared to baseline. The results suggest that 6-month DRSP+EE treatment decreases bone turnover.

Adult↗
PubMed1982

Effects of ethinyl-estradiol/noretisterone combinations on serum lipoproteins.

Eleven healthy young women (age range 20-28 years) were given three different oral contraceptives (OCs) in random order, each contraceptive for 3 months. Smoking, eating, drinking and habits of physical activity were similar throughout the study period. The combinations were: ethinyl-estradiol/noretisterone (EE/NET) 35 micrograms/0.5 mg, 35 micrograms/1 mg and 50 micrograms/1 mg. The 35/0.5 and the 50/1 EE/NET combinations led to significant weight increases of 2.4 and 1.7 kg, respectively. All EE/NET combinations produced LDL-TG increases, from a pretreatment value of 0.28 +/- 0.04 (SD) mmol/l to 0.34 +/- 0.07, 0.35 +/- 0.06 and 0.42 +/- 0.13 mmol/l (P less than 0.01 for all). LDL-cholesterol increased from 2.99 +/- 0.63 mmol/l to 3.35 +/- 0.62 (P less than 0.01) after 35/1 treatment and to 3.43 +/- 0.62 mmol/l (P less than 0.001) after 50/1 treatment. These two EE/NET combinations also caused significant reductions of HDL-cholesterol, in both cases from a pretreatment value of 1.75 +/- 0.16 mmol/l to 1.64 +/- 0.24 mmol/l (P less than 0.05). Since all values after EE/NET treatment remained well within normal ranges, these low-dose OCs probably have little effect on the development of atherosclerosis due to serum lipoprotein abnormalities. However, our findings suggest that OCs may interfere with the cholesterol ester/TG exchange between LDL and HDL.

Adult↗
PubMed2003

Expression of estrogen receptor alpha and beta in the uterus and vagina of immature rats treated with 17-ethinyl estradiol.

The action of estrogen on target organs has been actively studied with the discovery of estrogen receptor (ER) beta. This study was carried out to examine the expression of ERalpha and ERbeta in the uterus and the vagina of immature Sprague-Dawley rats treated with 17-ethinyl estradiol (EE). Twenty days old rats were subcutaneously treated with EE at the doses of 0 (vehicle control), 0.03, 0.3, 1.0, 3.0, and 10.0 microg/kg/day for three consecutive days. The treatment of EE at the doses of 0.3, 1.0, 3.0 and 10.0 microg/kg/day significantly increased the weights of the uterus and vagina of rats (p<0.01) and retained fluid in the uterus of rats. At the high doses of 3.0 and 10.0 microg/kg/day, the treatment of EE caused an increase in the uterine height, hypertrophy, and a decrease in the expression of ERalpha and ERbeta in the uterine luminal and glandular epithelium. The treatment of EE at the doses of 3.0 and 10.0 microg/kg/day also caused cornification and a decrease in the expression of ERalpha and ERbeta in the vaginal epithelium. These results suggest that the EE treatment decrease the expression of ERalpha and ERbeta in the uterus and vagina of immature rats and that may be associated with the morphological changes such as increase in the uterine height, hypertrophy of the uterine epithelium, and cornification of the vagina.

Animals↗
PubMed1991

[Cyclic ethinyl estradiol and medroxyprogesterone in climacteric women. Their clinicAL efficacy and patterns of uterine bleeding].

The study evaluated the clinical efficacy substitutive hormonotherapy regime in a group of 40 postmenopausal, women with moderate to severe symptomatology and negative progesterone challenge test. Each cycle consisted in the administration of 15 micrograms of ethinyl estradiol during 21 days, plus 10 mg medroxyprogesterone acetate (MPA) the last 10 days. Each patient received four cycles of therapy with 10 days of interval between them. The global clinical response was evaluated as favorable (excellent and good responses) in 97.5% of the patients. All the patients showed an improvement of the vaginal trophism (colpocytology). The great majority of the women experimented cyclical bleeding as consequence of the treatment. The post-therapeutic bleeding (Withdrawal) was the predominant bleeding pattern. This fact suggests that the 10 mg of MPA added daily during 10 days could allow a suitable opposition to the estrogenic proliferative effect inducing an adequate secretory response and the subsequent endometrial desquamation.

Climacteric↗
PubMed2003

In utero through lactational exposure to ethinyl estradiol induces cleft phallus and delayed ovarian dysfunction in the offspring.

Most of the attention currently focused on endocrine-active chemicals is directed to their effects on the development of offspring exposed to them in utero or during the neonatal period. Pregnant Crj:CD(SD)IGS rats were given ethinyl estradiol (EE) orally in doses of 0.5-50 microg/kg/day from gestational day 7 to postnatal day 18, and their offspring were examined for its effects. Our previous study according to a similar protocol demonstrated the occurrence of cleft phallus in the female offspring exposed to 50 microg/kg of EE in utero and during the lactation period. The present study was designed to assess (1) the reproducibility of the induction of cleft phallus, (2) the fertility of female rats with cleft phallus, and (3) whether any delayed effects, possibly delayed anovulation, were induced. At 50 microg/kg cleft phallus was observed in almost all of the female offspring, and slight retardation of body weight gain was detected in both sexes. At 15-17 weeks of age the animals with cleft phallus could copulate and had fertility comparable to the control group. At 6 months of age, on the other hand, 6/8 of the female offspring at 50 microg/kg exhibited abnormal cyclicity, including persistent estrus, and histological examination revealed follicular cysts and absence of corpora lutea in the ovaries of the rats with persistent estrus. These findings are consistent with delayed anovulation syndrome. The results suggest that observation of cyclicity at 6 months old is able to detect possible delayed ovarian dysfunction induced by perinatal exposure to chemicals.

Abnormalities, Drug-Induced↗
PubMed1988

Modulation of hepatic cholesterol metabolism by ethinyl estradiol and norgestrel.

Previous investigators reported that certain combination oral contraceptives are associated with significant alterations in serum lipid concentrations, namely a decrease in high density lipoprotein and increase in low density lipoprotein fractions. The mechanism(s) responsible for these changes remain unclear. In the present study we sought to determine the effect of the oral contraceptive components, ethinyl estradiol (EE) and norgestrel (N) on hepatic cholesterol metabolism, specifically on 3-hydroxy-3-methylglutaryl coenzyme A (HMG) reductase. Forty-eight cycling female Sprague-Dawley rats were divided into six groups and treated daily with either 0.1 mg or 1.0 mg EE daily, 1.0 mg or 10.0 mg N daily, or 0.1/1.0 mg or 1.0/10.0 mg EE/N in combination daily. Twelve age- and weight-matched animals served as controls. No significant changes in hepatic HMG reductase activity were observed between those groups treated with either EE or N alone and the control group. However, hepatic HMG reductase activity was increased significantly in both EE/N combination-treated groups when compared to controls, the EE-treated groups and the N-treated groups. These results are suggestive that the changes in serum lipids noted clinically in association with oral contraceptive use may be related to the induction specifically of hepatic HMG reductase activity and subsequent changes in cellular cholesterol synthesis or metabolism.

Animals↗
PubMedDate not supplied

Hemostatic effects of two oral contraceptives containing low doses of ethinyl estradiol and either gestodene or norgestimate: an open, randomized, parallel-group study.

OBJECTIVE: To determine effects on blood clotting of two modern low-dose monophasic oral contraceptives. SUBJECTS AND METHODS: We measured in vivo markers of intravascular coagulatory and fibrinolytic activity in 40 volunteers randomly assigned to one of two low-dose oral contraceptives (OCs) for 6 months; one contained 35 micrograms of ethinyl estradiol (EE) plus 250 micrograms of norgestimate and the other, 30 micrograms of EE plus 75 micrograms of gestodene. RESULTS: Both formulations increased coagulatory as well as fibrinolytic activity over baseline: circulating reactive products of thrombin increased by 40%, and plasmin activity by 60%, after 3 months of treatment. Six months of OC use increased hemostatic activity substantially over that with 3 months of use. Differences between both OC formulations were marginal and clinically insignificant. CONCLUSION: The data suggest an EE-dose-dependent, balanced activation of in vivo coagulation and fibrinolysis in users of currently available, combined OCs. However, there is considerable consumption of coagulation inhibiting factors, suggesting that women with congenital deficiencies of antithrombin III and protein C should not use combined OCs.

Adult↗
PubMed1998

Comparison of cyproterone acetate plus ethinyl estradiol and finasteride in the treatment of hirsutism.

The aim of this study was to compare the clinical efficacy and safety of low dose cyproterone acetate-estrogen combination (Diane) and the 5 alpha-reductase inhibitor finasteride in the treatment of hirsutism. Fourty-two women with hirsutism were included in the study. Twenty-one patients treated with cyproterone acetate (CPA) 2 mg and ethinyl estradiol (E) 35 micrograms daily on days 5-25 of the menstrual cycle, 21 with finasteride 5 mg daily. Hirsutism score, hormone levels, multiscreen blood chemistry and side effects were evaluated at three-monthly intervals for 9 months. A significant decrease in hirsutism score as compared to baseline was observed after 9 months with either CPA + E (Diane) (mean +/- SE, 15.81 +/- 1.19 vs 8.38 +/- 1.21) or finasteride treatment (17.81 +/- 1.05 vs 10.86 +/- 0.91) (p < 0.0005). The reductions in hirsutism scores (mean% +/- SE) were 14.23 +/- 2.29 vs 19.77 +/- 2.22 (p < 0.05) at 3, 40.23 +/- 4.58 vs 29.49 +/- 2.69 (p < 0.02) at 6 and 50.99 +/- 4.13 vs 39.87 +/- 3.30 (p < 0.02) at 9 months in CPA + E and finasteride groups, respectively. No significant changes were observed in hormone levels during finasteride treatment. Serum free testosterone significantly decreased at the third month of treatment, and remained suppressed for the duration of treatment in CPA + E group. DHEAS levels also decreased significantly after 6 and 9 months of therapy with CPA + E. SHBG significantly increased during CPA + E treatment. We conclude that both drugs are effective and well tolerated, but CPA + E appears to be more effective than 5 alpha-reductase inhibitor finasteride in long-term treatment of hirsute women. Diane is also a cost-effective drug.

5-alpha Reductase Inhibitors↗
PubMed2001

Low dose of ethinyl estradiol can reverse the antiestrogenic effects of clomiphene citrate on endometrium.

Fifty healthy, voluntary patients aged between 20 and 30 years with regular menstruation and plasmatic progesterone level >10 ng/ml at the midluteal phase have been enrolled in this study. They were randomly treated with clomiphene citrate (CC; group A) or CC + ethinyl estradiol (0.05 mg group B, or 0.02 mg group C). We estimated the difference in uterine artery pulsatily index, endometrial thickness and histological dating and morphometric analysis of endometrium. No significant differences in Pulsatility Index values and in the number of preovulatory follicles were noted. The difference between endometrial thickness, histological dating and morphometric analysis of the endometrium were statistically different between groups B and C vs. A. Our study shows that CC has a deleterious effect on endometrium maturity and that adding ethinyl-E(2) produces a favorable endometrial response even with very low doses.

Adult↗
PubMed2005

Pharmacokinetic interaction of solifenacin with an oral contraceptive containing ethinyl estradiol and levonorgestrel in healthy women: a double-blind, placebo-controlled study.

BACKGROUND: Solifenacin succinate (YM905; Vesicare, Astellas Pharma Inc., Tokyo, Japan) is a new once-daily, orally administered muscarinic receptor antagonist under investigation for the treatment of overactive bladder. OBJECTIVE: The aim of this study was to evaluate the effect of solifenacin on the pharmacokinetic (PK) parameters of an oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LNG). METHODS: In a double-blind, placebo-controlled, 2-period, crossover study, 24 healthy, young, white women received a combined OC (EE 30 microg + LNG 150 microg) daily for two 21-day cycles, separated by a 7-day washout. On day 12 of each cycle, subjects began a 10-day regimen of solifenacin 10 mg QD, which is 2 times the suggested starting dose, or placebo. Subjects crossed over to the other treatment arm for the second cycle. Primary PK end points were C(max) and AUC from time 0 to 24 hours (AUC(0-24 h)) for EE and LNG. Women ranged in age from 20 to 37 years and had a mean body weight of 64 kg, mean height of 167.4 cm, and mean body mass index of 23 kg/m2. Seven women had never smoked, while 5 were former smokers and 12 were regular smokers. Safety assessments included the nature, frequency, and severity of spontaneously reported or observed adverse events, vital signs, electrocardiogram, laboratory values, and physical examination. RESULTS: Statistical analysis of AUC(0-24 h)/product of baseline concentration and total blood sampling time, and C(max)/baseline concentration ratios of solifenacin versus placebo for EE and LNG found the 90% CI to be within the predefined range of 0.8 to 1.25 (EE: 0.854-1.164 and 0.822-1.167; LNG: 0.920-1.125 and 0.910-1.139). The number of samples with non-quantifiable luteinizing hormone (LH) and folliclestimulating hormone (FSH) levels were comparable after administration of the OC with either solifenacin or placebo. The adverse event most frequently reported was dry mouth (solifenacin, n = 25 [9 mild, 13 moderate, and 3 severe] vs placebo, n = 1 [moderate]). There were no clinically relevant effects on vital signs, electrocardiogram, or laboratory parameters. CONCLUSIONS: A PK interaction between solifenacin and the OC containing EE and LNG was not found in this study. Solifenacin was not found to have altered suppression of LH or FSH. The drug was well tolerated in these healthy, young, white, adult female volunteers.

Adult↗